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Business Insight presented by Arlington Dermatology How Safe Are Clinical Trials? Every time we see a patient who might be a good candidate for a study, we offer it to that patient and explain what it is all about. The first-time introduction is quite difficult. The question comes right away: why would you be experimenting? I do not want to be a guinea pig. We understand the hesitation and initial rejection. Yes, it is experimenting in some sense, but it might be a better and more effective option than anything else we can prescribe. Many current drugs on the market were developed exactly the same way, by experimenting, and many of them have some side effects that are not 100% safe. We all want to have better medication and safer medication. The only way to reach that goal is to conduct clinical trials and participate in them. Years ago, we had very few drugs for psoriasis, Most of them had quite extensive side effects, including liver damage and increased infections. Today, we have multi- variety of injections and oral agents and many of them are more effective and safer. Just ask anyone taking Skyrizi or Taltz. And have them remind you how it worked 20 years ago. These two drugs were developed exactly through a pharmaceutical sponsor from a foreign clinical trials, running for years. As a matter of fact, some studies are still on-going, seeking long-term safety and efficacy data. Their participants are very unhappy when we have to close out their participation at the end. Our practice has been conducting clinical studies for 17 years. We are very selective about which studies we want to be on, and which ones are simply not suited for us and our patients. What are we looking at? First of with sponsors. The amount of work is all, we look through all prior safety data and seek any information that would disclose potential toxicity, infections, or other safety safe and effective. The staff will ask you similar issues. Secondly, we look at the study design. How many patients will receive placebo and for how long? Is there a safety blood work and other testing frequently enough to evaluate the patients' safety? How often patients must come to the clinic? Is there patients' compensation for their visits? The check marks go on. We never agree to conduct the study are free of charge. We will not ask for insurance that would not present much higher benefit or money. We will just tell you our stories. than risk. And we evaluate that risk/benefit ration at every visit. There were studies we denied participating in and there were the ones we started and stopped very shortly. Why? We discovered that what we expected turned to be something different. Patients' unfriendly. Impossible to meet criteria. Years ago, we worked with country who depended on translated to English protocol and design. While we really wanted to try the new drug, we decided not to do so because there were too many errors in translation. A lot of responsibilities fall on the research staff. It is a very fulfilling job if everything goes well. It becomes a very frustrating work if there are problems with communication overwhelming. But it makes sense- we protect patients and assure that the new drug will be questions over and over, they will repeat some instructions many times. But most of all, they will try to make it a fun and positive experience. Something that you will possibly want to repeat in the future. If you want to learn more, please call us. Please, remember that all the research visits Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net Business Insight presented by Arlington Dermatology How Safe Are Clinical Trials? Every time we see a patient who might be a good candidate for a study, we offer it to that patient and explain what it is all about. The first-time introduction is quite difficult. The question comes right away: why would you be experimenting? I do not want to be a guinea pig. We understand the hesitation and initial rejection. Yes, it is experimenting in some sense, but it might be a better and more effective option than anything else we can prescribe. Many current drugs on the market were developed exactly the same way, by experimenting, and many of them have some side effects that are not 100% safe. We all want to have better medication and safer medication. The only way to reach that goal is to conduct clinical trials and participate in them. Years ago, we had very few drugs for psoriasis, Most of them had quite extensive side effects, including liver damage and increased infections. Today, we have multi- variety of injections and oral agents and many of them are more effective and safer. Just ask anyone taking Skyrizi or Taltz. And have them remind you how it worked 20 years ago. These two drugs were developed exactly through a pharmaceutical sponsor from a foreign clinical trials, running for years. As a matter of fact, some studies are still on-going, seeking long-term safety and efficacy data. Their participants are very unhappy when we have to close out their participation at the end. Our practice has been conducting clinical studies for 17 years. We are very selective about which studies we want to be on, and which ones are simply not suited for us and our patients. What are we looking at? First of with sponsors. The amount of work is all, we look through all prior safety data and seek any information that would disclose potential toxicity, infections, or other safety safe and effective. The staff will ask you similar issues. Secondly, we look at the study design. How many patients will receive placebo and for how long? Is there a safety blood work and other testing frequently enough to evaluate the patients' safety? How often patients must come to the clinic? Is there patients' compensation for their visits? The check marks go on. We never agree to conduct the study are free of charge. We will not ask for insurance that would not present much higher benefit or money. We will just tell you our stories. than risk. And we evaluate that risk/benefit ration at every visit. There were studies we denied participating in and there were the ones we started and stopped very shortly. Why? We discovered that what we expected turned to be something different. Patients' unfriendly. Impossible to meet criteria. Years ago, we worked with country who depended on translated to English protocol and design. While we really wanted to try the new drug, we decided not to do so because there were too many errors in translation. A lot of responsibilities fall on the research staff. It is a very fulfilling job if everything goes well. It becomes a very frustrating work if there are problems with communication overwhelming. But it makes sense- we protect patients and assure that the new drug will be questions over and over, they will repeat some instructions many times. But most of all, they will try to make it a fun and positive experience. Something that you will possibly want to repeat in the future. If you want to learn more, please call us. Please, remember that all the research visits Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net